Device Recall Atrium

  • Model / Serial
    Lot #s 10300923, 10311229, 10318744, 10336321, 10348453
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA, US Virgin Islands, South Africa, Austria, Taiwan, Venezuela, and Saudi Arabia.
  • Product Description
    HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip, || Atrium Code # 9128, || Size (Fr) 28, || # Eyelets 5, || 10 per case
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Atrium Medical Corporation, 5 Wentworth Dr, Hudson NH 03051-4929
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

43 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot Numbers; 10137320, 10116878, 10101974
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, including CA, and PA.
  • Product Description
    Atrium Express Dry Seal Chest Drain with Sterile Fluid Path Package || Model Number: 4050-170N
  • Manufacturer
  • Model / Serial
    Lot number starting with 10883097 and the ending lot number 10913346. (All units in between and including these two numbers).  To evacuate air and/or fluid from the chest cavity or mediastinum.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.
  • Product Description
    Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System with stopcock and in-line connectors Sterile fluid path packaging || Product Code: 2050-070. || To evacuate air and/or fluid from the chest cavity or mediastinum.
  • Manufacturer
  • Model / Serial
    Lot number starting with 10883097 and the ending lot number 10913346. (All units in between and including these two numbers)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.
  • Product Description
    Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock and in-line connectors || Product Code: 2052-000. || To evacuate air and/or fluid from the chest cavity or mediastinum.
  • Manufacturer
  • Model / Serial
    Lot number starting with 10883097 and the ending lot number 10913346. ( All units in between and including these two numbers)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.
  • Product Description
    Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock; .Product Code: 2052-300. || To evacuate air and/or fluid from the chest cavity or mediastinum.
  • Manufacturer
  • Model / Serial
    Lot number starting with 10883097 and the ending lot number 10913346. (All units in between and including these two numbers)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.
  • Product Description
    Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with in-line connectors Product Code: 3650-100. || To evacuate air and/or fluid from the chest cavity or mediastinum.
  • Manufacturer
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